Pegylated-Interferon and Ribavirin Plus Metformin in the Treatment of Chronic HCV Infection and Insulin Resistance

• Status: Unknown status
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Chronic hepatitis C virus (HCV) infection is associated with an increased risk for the development of type 2 diabetes and HCV infection itself may promote insulin resistance, irrespective of the severity of liver disease.

Insulin resistance seems to be genotype specific and may play a role in fibrogenesis in chronic hepatitis C.

In an "in vitro" model, increased levels of insulin may promote increased HCV replication.

RATIONALE Decreased insulin resistance and reduced hyperinsulinemia may facilitate the efficacy of anti-viral drugs on HCV replication.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Turin, Italy
• Treatments: Insulin; Interferons; Metformin; Ribavirin

Criteria

Inclusion Criteria:

1. No previous antiviral treatment

2. Persistently elevated alanine aminotransferase (ALT) and quantifiable HCV-RNA (>2000 copies/ml)

3. Liver biopsy (within 12 months) consistent with CHC with or without cirrhosis

4. Compensated liver disease (Child-Pugh grade A)

5. Insulin resistance (evaluated by HOMA-R and OGTT)

6. Negative pregnancy test

Exclusion Criteria:

1. Type 2 Diabetes (according to ADA criteria)

2. BMI > 30

3. Alcohol consumption > 30 g/day

4. Other forms of liver disease (HBV, autoimmune, genetic), HIV infection.

5. Anemia

6. Psychiatric disease

7. Thyroid disease poorly controlled

8. Overt cirrhosis, hepatocellular carcinoma

9. Significant cardiac, renal, pulmonary disease, seizures.